L-Glutamine Therapy for Sickle Cell Anemia

This study is currently recruiting participants.

Verified by FDA Office of Orphan Products Development, January 2002

First Received: January 24, 2002 Last Updated: June 23, 2005 History of Changes

Sponsor:	FDA Office of Orphan Products Development
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00029887

Purpose

This is a study to determine the efficacy of L-glutamine as therapy for sickle cell anemia and sickle O-thalassemia.

Condition	Intervention	Phase
Anemia, Sickle Cell Thalassemia	Drug: L-glutamine	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	L-Glutamine Therapy for Sickle Cell Anemia

Resource links provided by NLM:

Genetics Home Reference related topics: sickle cell disease

MedlinePlus related topics: Anemia Sickle Cell Anemia Thalassemia

Drug Information available for: Glutamine

U.S. FDA Resources

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:	80
Study Start Date:	September 2001
Estimated Study Completion Date:	September 2004

Detailed Description:

Sickle cell anemia is one of the most common and devastating hereditary disorders with significant morbidity and mortality affecting individuals of African-American heritage. No safe effective therapy is yet available. An ideal agent would be one that is readily available, effective, and safe even with chronic use. Early studies using L-glutamine in a few patients show promising results. This is an amino acid that has been used widely for other purposes and shown to be safe.

Patients are assigned randomly to receive L-glutamine or placebo orally 3 times a day for 24 weeks after which patients will cross over to the other treatment arm for 24 weeks. Clinical parameters, adverse effects attributable to L-glutamine, and physiological parameters will be monitored throughout the study.

Eligibility

Ages Eligible for Study:	5 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Diagnosis of sickle cell anemia or sickle beta O-thalassemia
History of at least 3 episodes of painful crisis during the past 12 months
PT INR no greater than 2.0
Albumin at least 3.0 g/dL

Exclusion criteria:

Any other significant medical condition, including diabetes mellitus (with untreated fasting blood sugar greater than 115), that required hospitalization within the past 2 months
Received any blood products within the past 3 months
History of stroke
Received other antisickling agents within the past 12 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00029887

Locations

United States, California
Harbor-UCLA Research and Education Institute	Recruiting
Torrance, California, United States, 90502
Contact: Yutaka Niihara, M.D. 310-222-3695 ysniihara@aol.com
Principal Investigator: Yutaka Niihara, M.D.

Sponsors and Collaborators

FDA Office of Orphan Products Development

More Information

No publications provided

Study ID Numbers:	FD-R-2028-01, G002028;, FD-R-002028-01
Study First Received:	January 24, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00029887 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by FDA Office of Orphan Products Development:

Sickle O-thalassemia

Additional relevant MeSH terms:

Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Hematologic Diseases
Hemoglobinopathies

Anemia
Anemia, Hemolytic
Thalassemia
Anemia, Sickle Cell

ClinicalTrials.gov processed this record on November 05, 2009